What happens if I overdose Terbute?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include anxiety; chest pain; drowsiness; dry mouth; fainting; fast or irregular heartbeat; gasping; muscle cramps; nervousness; seizures; severe or persistent dizziness, headache, or nausea; sweating; tremor; unconsciousness; vomiting.
Proper storage of Terbute tablets:
Store Terbute tablets at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Terbute tablets out of the reach of children and away from pets.
Overdose of Terbute in details
The median subcutaneous lethal dose of Terbute sulfate in mature rats is approximately 165 mg/kg (approximately 90 times the maximum recommended daily oral dose for adults on a mg/m2 basis). The median subcutaneous lethal dose of Terbute sulfate in young rats is approximately 2000 mg/kg (approximately 1100 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur.
There is no specific antidote. Treatment consists of discontinuation of Terbute sulfate together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Terbute sulfate.
In the alert patient who has taken excessive oral medication, the stomach should be emptied by induced emesis followed by lavage. In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before lavage, and emesis should not be induced. Instillation of activated charcoal slurry may help reduce absorption of Terbute. Adequate respiratory exchange should be maintained, and cardiac and respiratory support provided as needed. The patient should be monitored until signs and symptoms of overdosage have subsided.
What should I avoid while taking Terbute?
Avoid situations that may worsen your respiratory condition such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.
Terbute warnings
Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Terbute sulfate than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Use of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
Cardiovascular Effects
Terbute sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Terbute sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Terbute sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Seizures
There have been rare reports of seizures in patients receiving Terbute; seizures did not recur in these patients after the drug was discontinued.
What should I discuss with my healthcare provider before taking Terbute?
Some medical conditions may interact with Terbute tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart disease, an irregular heartbeat, high blood pressure, an overactive thyroid, diabetes, a history of seizures, or an adrenal gland tumor
- if you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) within the past 14 days
Some MEDICINES MAY INTERACT with Terbute tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as life-threatening irregular heartbeat, may be increased
- Diuretics (eg, furosemide) or other sympathomimetic medicines (eg, pseudoephedrine, albuterol) because the risk of their side effects may be increased by Terbute tablets
- Beta-blockers (eg, propranolol) because they may decrease Terbute tablets's effectiveness
- Insulin because its effectiveness may be decreased by Terbute tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Terbute tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Terbute precautions
General
Terbute, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; hyperthyroidism; diabetes mellitus; hypersensitivity to sympathomimetic amines; and convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Immediate hypersensitivity reactions and exacerbation of bronchospasm have been reported after Terbute administration.
Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Large doses of intravenous Terbute sulfate have been reported to aggravate preexisting diabetes and ketoacidosis.
Information for Patients
The action of Terbute sulfate should last up to 6 hours or longer. Terbute sulfate should not be used more frequently than recommended. Do not increase the dose or frequency of Terbute sulfate without consulting your physician. If you find that treatment with Terbute sulfate becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While taking Terbute sulfate, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Terbute sulfate. Effective and safe use of Terbute sulfate includes an understanding of the way that it should be administered.
Drug Interactions
The concomitant use of Terbute sulfate with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with Terbute sulfate.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
Terbute sulfate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of Terbute sulfate on the vascular system may be potentiated.
Beta-Blockers
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Terbute sulfate, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Diuretics
The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in Sprague-Dawley rats, Terbute sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 50 mg/kg, and above (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis). In a 21-month study in CD-1 mice, Terbute sulfate showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 55 times the maximum recommended daily oral dose for adults on a mg/m2 basis). The mutagenicity potential of Terbute sulfate has not been determined.
Reproduction studies in rats using Terbute sulfate demonstrated no impairment of fertility at oral doses up to 50 mg/kg (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
Pregnancy
Teratogenic Effects
Pregnancy Category C
There are no adequate and well-controlled studies of Terbute sulfate in pregnant women. Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with Terbute during the late stage of pregnancy and lactation period. Terbute exposures in rat dams were approximately 6.5 times the common human dose in adults of 15 mg/day, on a mg/m2 basis.
Oral Terbute sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, Terbute sulfate should not be used for tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of Terbute sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.
In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received Terbute sulfate at oral doses up to 50 mg/kg/day, approximately 32 and 65 times, respectively, the maximum recommended daily oral dose for adults, on a mg/m2 basis.
Terbute sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Labor and Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of Terbute sulfate for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Terbute crosses the placenta. After single dose IV administration of Terbute to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of Terbute were found to range from 11% to 48% of the maternal blood levels.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Therefore, Terbute sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Pediatric Use
Terbute sulfate is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.
Geriatric Use
Clinical studies of Terbute sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What happens if I miss a dose of Terbute?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
References
- DailyMed. "TERBUTALINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "terbutaline". http://www.drugbank.ca/drugs/DB00871 (accessed September 17, 2018).
- MeSH. "Tocolytic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
